Intubation is a medical procedure in which an endotracheal tube (hereinafter “ET”) is positioned into the trachea, effectively bypassing the mouth, nose and throat, to provide oxygen directly to the lungs. Intubation is a common procedure performed on any person who cannot manage their own airway. In a hospital setting, this includes people receiving general anesthetic in preparation of surgery, but also includes many emergency situations, where injury and trauma impairs one's airway.
Millions of intubations are performed each year in the U.S. but despite this frequency, complications due to improper or difficult intubations are an all too common occurrence. Injuries as a result of improper intubation account for nearly 25% of all anesthesiology malpractice claims. Failed ET intubations are one of the largest problems facing surgical teams and emergency responders today. Yearly there are hundreds of malpractice lawsuits filed relating to mishaps during intubation. Many of these lawsuits are quite serious stemming from serious injury and even death of the patient.
The insertion of an ET is often accomplished using a laryngoscope, but using a laryngoscope requires skill and proper training. The laryngoscope is inserted into the mouth to push away the tongue and lift the epiglottis so that a view of the glottis (space between the vocal cords) is possible. The goal is then to feed the ET into the airway and the trachea instead of the esophagus (which is located directly behind the trachea), and then to maintain such placement during patient transport or until the ET is removed. If the ET is mistakenly placed in the esophagus the mistake can be fatal or lead to brain injury and permanent disability. Statistically, about 8% of all intubations are difficult, which leads to an increased chance of improper intubation.
The problem is that even when a patient's mouth is open, even using a laryngoscope, the vocal chords are not visible, and by feeding the ET into the airway, even visual inspection of the glottis becomes blocked. Even if properly placed, a problem may still occur when proper placement of the ET is re-checked following placement for example, when patients are transported by ambulance after the patient has been intubated by emergency medical services, where the movement might have dislodged, or partially dislodged the ET.
There are generally three types of instruments that have been utilized to provide video assisted tracheal intubation. The first is the ET itself, the second is the laryngoscope blade, and the third is an intubation stylet, i.e. a device which is slid through the center of the ET and aids in the insertion of the ET into the airway. In each case, an image is transmitted, usually via fiber optic material or the like, from the tip of the instrument to a display that is visible to the doctor during use of the instrument.
With respect to the first two types of instruments, namely the ET and the laryngoscope blade, these generally tend to be modifications of the regularly utilized instruments. Specifically, some form of ultra thin fiber optic is integrated into the instrument which feeds to a display monitor at the end of the instrument or remote of the instrument. Such video-intuboscopy and video laryngoscopy have generally been utilized in hospital settings where extensive monitor equipment is available. Such devices have provided limited, if any, assistance to first responders such as EMS personnel. The video-optical intubation stylet that has been suggested also uses optical fibers for image transmission from the stylet tip to the video camera monitors. However, these also require remote imaging and provide difficult video monitoring, especially in emergency response conditions.
It has also been recently suggested to use video electronics, such as a miniature electric camera which is incorporated in the distal end of the endotracheal tube itself or the stylet. However, no practical implementation of such device has been suggested and no suitable display mechanism has been provided to facilitate usage by emergency responding personnel. Furthermore, most of these devices that have been suggested provide complex structure with inadequate monitoring for the convenience of the medical personnel utilizing such instruments.